Hive Stand-alone Anterior Lumbar Interbody System— 510(k) K200541

Name: FDA 510(k) clearance K200541
Creator: U.S. Food and Drug Administration
Published: 2020-04-28

Substantially Equivalent

Hd Lifesciences, LLC

FDA 510(k) clearance K200541 for Hive Stand-alone Anterior Lumbar Interbody System, Substantially Equivalent on 2020-04-28. Applicant: Hd Lifesciences, LLC. Device class: 2.

Clearance details

Applicant: Hd Lifesciences, LLC
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2020-03-03
Decision date: 2020-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVD

view all

K261408 — SABER-XA System2026-08-03
K261809 — Interwedge® Standalone Lateral2026-07-31
K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System2026-07-15
K260810 — Anteralign LS coverplate2026-06-10
K254202 — MectaLIF 3D Metal Anterior2026-05-05

More clearances from Hd Lifesciences, LLC

view all

K180364 — HD LifeSciences Cervical IBFD System2018-06-27
K170676 — HD Lumbar Interbody System2017-07-13

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.